NITOM LOCKING FACEBOW— 510(k) K980245

Substantially Equivalent

Ortho Kinetics Corp.

FDA 510(k) clearance K980245 for NITOM LOCKING FACEBOW, Substantially Equivalent on 1998-04-21. Applicant: Ortho Kinetics Corp.. Device class: 2.

Clearance details

Applicant: Ortho Kinetics Corp.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1998-01-23
Decision date: 1998-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZB

K202855 — Orthodontic Facemask2021-06-21
K162543 — Reverse Pull Adjustable Facemask2017-08-28
K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF2011-10-03
K103019 — KJ MASK2011-06-09
K052553 — NITOM LOCKING FACEBOW2005-12-22

More clearances from Ortho Kinetics Corp.

K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM1998-09-04
K980436 — CLASS III REVERSE PULL FACEMASK1998-04-27
K980864 — POWER COINS GLOW IN THE DARK LIGATURES1998-04-20
K980151 — RELEASABLE FORCE MODULE1998-04-06
K980195 — FACEBOW1998-03-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.